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Completed

NCT Number: NCT05211063

Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders

Previous research has shown the efficacy of CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. The main objective of this study is to evaluate the efficacy of CROCUVIS® in computer vision syndrome, sleep and mood disorders in a sample of university students who use digital devices.

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Key information

Conditions

Computer Vision Syndrome Mental Disorders Mood Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alicante

San Vicent del Raspeig, Alicante, 03690, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CVS-Q© score ≥6.
  • Age between 18 and 40 years (both inclusive).
  • Exposure to digital devices 4 hours a day, at least five days a week or more and maintain the same level of exposure throughout the study period.

Exclusion criteria

  • Monocular corrected distance visual acuity >0.0 LogMAR.
  • Ocular pathology under treatment at the time of the study.
  • Previous ocular surgery that could affect the tear film or the ocular surface.
  • Ocular Surface Disease Index (OSDI) questionnaire score ≥13.
  • Previous diagnosis or history of dry eye syndrome and/or blepharitis.
  • Regular (daily) use of rigid or soft contact lenses ≥3 days a week.
  • Regular use of any ocular lubricant.
  • History of oral intake of dietary supplements, with or without herbal ingredients, intended to contribute, maintain or reduce the risk of suffering diseases related to visual function, mood or sleep within the four weeks before the study enrollment.
  • Systemic disease:
  • Uncontrolled hypertension (systolic/diastolic blood pressure >140/90 mmHg).
  • Uncontrolled diabetes mellitus (fasting blood glucose level >180 mg/dL).
  • Rheumatoid arthritis.
  • Tumor disease.
  • Active hepatitis (type B and C).
  • Active infectious disease.
  • Kidney disease that compromises diuresis.
  • Current systemic treatment or in the last 3 months with drugs that may interfere with the results, for example:
  • Opioids.
  • Antipsychotics.
  • Antibiotics (tetracyclines, sulfonamides)
  • Antiarthritic drugs (hydroxychloroquine)
  • Hypotensive drugs (beta-blockers)
  • Anticoagulants (heparin, warfarin, or clopidogrel)
  • Antidepressants (such as fluoxetine, among others)
  • Hypnotics (eg, benzodiazepines)
  • Habitual smoker and/or alcohol drinker. More than 3 cigarettes per day and/or more than 3 Standard Drink Units (SDU) per week, including weekends. SDU is defined as the consumption of 10 ml of alcohol.
  • Regular job with rotating shifts including night shift in the last month (including weekends).
  • Pregnancy or breastfeeding (also excludes recent pregnancy within the last 3 months) and women planning to become pregnant.
  • Participation in another clinical trial in the last 3 months.
  • Take any type of dietary supplements with botanical components in the last month.

Treatment and study plan

Saffron extract (Crocus sativus)

Dietary Supplement

Daily intake of one tablet for 42 days.

Placebo

Dietary Supplement

Daily intake of one tablet for 42 days.

Primary outcomes

  1. Change from baseline computer vision syndrome at 14, 28 and 42 days

    Time frame: 0 (baseline), 14, 28 and 42 days

    Measured with the Computer Vision Syndrome Questionnaire (CVS-Q©). It evaluates the frequency and intensity with which 16 symptoms are perceived over the time of use of digital devices. The score ranges from 0 to 32; computer vision syndrome is considered ≥6. The higher score a subject gained, the worsen ocular condition he/she experienced.

  2. Change from baseline sleep disorders at 14, 28 and 42 days

    Time frame: 0 (baseline), 14, 28 and 42 days

    Measured with the Insomnia Severity Index (ISI). It evaluates 7 items. The score ranges from 0 to 28 (worst). Each item is evaluated on a 5-point Likert scale (from 0 to 4). The final score is obtained from the sum of the responses of all items; insomnia is considered ≥8.

  3. Change from baseline mood at 14, 28 and 42 days

    Time frame: 0 (baseline), 14, 28 and 42 days

    Measured with the Profile of Mood States (POMS). It evaluates 58 items that form 6 factors (tension, depression, anger, vigour, fatigue, and confusion). The score ranges from 68 to 300 (worst mood). Each item is evaluated with a 5-point Likert scale (from 0 to 4). The score of each factor is obtained from the sum of the responses of all the items that define it.

    Total Mood Disturbance = 100+ (Tension + Depression + Anger + Fatigue + Confusion) - Vigour

Secondary outcomes

  1. Change from baseline quality of life related to health at 42 days

    Time frame: 0 (baseline) and 42 days

    Measured with Short Form-36 survey (SF-36). It evaluates 36 items that form 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores are weighted sums of the questions in each section. The score ranges from 0 to 100. Lower scores = more disability, higher scores = less disability.

  2. Satisfaction question

    Time frame: Last visit (42 day)

    A single satisfaction question. Participants must respond by selecting a number from a Likert scale from 0 to 5.

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Collaborators

  • Pharmactive Biotech Products S.L.U

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 27, 2022
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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